MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for MIDWEST STYLUS LITE 360S 791500 manufactured by Sirona Dental Systems Gmbh.
[184716249]
The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
Patient Sequence No: 1, Text Type: N, H10
[184716250]
It was reported that a bur fell out of a midwest stylus lite handpiece during use. The bur fell into a patient's mouth and was swallowed. Two weeks after the event, the patient had a second x-ray which confirmed the bur was lodged in the patient's digestive track. No further details are available as of this mdr evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614977-2020-00002 |
| MDR Report Key | 9802280 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KARL NITTINGER |
| Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
| Manufacturer City | YORK, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 8494424 |
| Manufacturer G1 | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Street | FABRIKSTRASSE 31 |
| Manufacturer City | BENSHEIM, HESSEN D-64625 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-64625 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDWEST STYLUS LITE 360S |
| Generic Name | HANDPIECE, AIR-POWERED, DENTAL |
| Product Code | EFB |
| Date Received | 2020-03-06 |
| Model Number | NA |
| Catalog Number | 791500 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRONA DENTAL SYSTEMS GMBH |
| Manufacturer Address | FABRIKSTRASSE 31 BENSHEIM, HESSEN D-64625 GM D-64625 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |